Updated findings from the Phase II INTELLECT study, presented at the World Conference on Lung Cancer (WCLC) 2024, demonstrate the sustained efficacy and safety of Qilu Pharmaceutical's iruplinalkib tablets (Qixinke®) in treating patients with anaplastic lymphoma kinase (ALK)-positive crizotinib-resistant non-small-cell lung cancer (NSCLC). The study's highlights were presented in a poster at the conference held in San Diego, California.
Iruplinalkib, a next-generation ALK/ROS1 kinase inhibitor, received approval from the NMPA in June 2023 for ALK-positive locally advanced or metastatic NSCLC patients who progressed on or were intolerant to crizotinib. It was further approved in January 2024 for first-line treatment of ALK-positive NSCLC.
INTELLECT Study: Efficacy and Safety Results
The INTELLECT study, led by Prof. Yuankai Shi, enrolled 146 subjects. As of December 29, 2023, with a median follow-up of 42.41 months, the study revealed a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, and the disease control rate (DCR) reached 94.5%. The median duration of response (DoR) was 14.06 months, and the median progression-free survival (PFS) was 14.55 months.
Activity in CNS Metastasis
In a subgroup of 90 patients with CNS metastasis at baseline, the ORR was 55.6%, and the DCR was 93.3%, according to RECIST v1.1 criteria. The median DoR and median PFS were 17.25 months, and the median OS was 43.01 months.
Based on RANO-BM criteria, intracranial complete response (CR) was achieved in 17 (18.9%) of the 90 patients with CNS metastasis at baseline. Among the 42 subjects with measurable intracranial lesions at baseline, the intracranial objective response rate (iORR) was 64.3%, while the intracranial disease control rate (iDCR) reached 95.2%.
Safety Profile
The safety profile showed a 93.8% incidence of treatment-related adverse events (TRAEs), with 30.8% being grade 3 or 4. The most common TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and increased alanine aminotransferase (37.0%). No new safety signals were identified during the extended follow-up.
The long-term follow-up results confirm that iruplinalkib provides a significant OS benefit with a consistent safety profile in patients with ALK-positive crizotinib-resistant advanced NSCLC.
